This invention related to endoscopes. More particularly, this invention relates to flexible fiberoptic endoscopes, i.e., endoscopes with flexible insertion members.
The flexible fiberoptic endoscope is considered according to the Food and Drug Association (FDA) and Centers for Disease Control and Prevention (CDC) to have the status of a semi-critical requirement for disinfection or sterilization. The definition of semi-critical is: “A device that comes into contact with intact mucous membranes and does not ordinarily penetrate sterile tissue”. These devices should receive at least high level disinfection, defined as the destruction of all vegetative microorganisms, mycobacteria, small or non-lipid viruses, medium or lipid viruses, fungal spores and bacterial spores. The steps to achieve such disinfection are long and arduous, and all healthcare personnel in the endoscopy suite must adhere to the standard infection control recommendations in order to protect both patients and healthcare workers.
Multi-society guidelines for reprocessing flexible gastrointestinal endoscopes were presented in a position paper and delineated the following steps that must be followed during disinfection. These steps include pressure/leak testing after each use, disconnecting all air and water suction valves, meticulously cleaning channels, the outside of the entire endoscope, and all valves and connectors with an enzymatic detergent. This is followed by flushing and brushing all accessible channels to remove all organic (e.g., blood, tissue) and other residues. All surfaces must be accessed. Brushes appropriate for the channels must be used, and bristles must contact all internal surf acres of the channels. Ultrasonic cleaning of the endoscopes is used to remove soil and organic material from hard-to-clean channels inaccessible to brushes. The FDA requires disinfection with 2% gluteraldehyde for 20 minutes at 20 degrees C. The endoscope must be completely immersed in the high level disinfectant/sterilant to ensure that all channels are perfused. An automated endoscope washer-disinfector is used to ensure that all channels are adequately disinfected. Before this process is initiated, channel connectors are attached to ensure exposure of all internal surfaces with the high level disinfectant/sterilant. If this process is interrupted, disinfection process must be initiated from the beginning. “Because of design flaws of the endoscope, the staff must routinely test for infectious organisms that may be left in the channels”. After high level disinfection, the channels must be rinsed with sterile, filtered or tap water to remove the disinfectant/sterilant. This is followed by flushing the channels with 70% to 90% ethyl alcohol and drying the channels with forced air. The disinfectant/sterilant is highly irritating to the colon if left inside the channels. A clinical picture similar to acute peritonitis may ensue if the colon is exposed to this noxious chemical. Personnel must use protective equipment such as gowns, eyewear, and respiratory protection devices to protect workers from exposure to the noxious chemicals. (Gastrointestinal Endoscopy, Volume 58 Number 1, July 2003 page 1).
This arduous process is necessary to avoid infection primarily because of the convoluted long and narrow channels of the endoscopes. Most infections have occurred because bio-burden was not completely removed from the channels. Sterilization is rendered useless if manual cleaning is not performed perfectly.